Quality control lapses found at Biovail factories. Michael Melia, The Associated Press. Published Wednesday, February 6, 2. AM EST. The first warning sign came when a sharp- eyed worker sorting pills noticed that the odd blue flecks dotting the finished drug capsules matched the paint on the factory doors. After the flecks were spotted again on the capsules, a blood- pressure medication called diltiazem, the plant began placing covers over drugs in carts in its manufacturing areas. Thirteen of the 2. United States come from plants on this island. But an investigation by The Associated Press has found dozens of examples over four years of lapses in quality control in the Puerto Rican pharmaceutical industry, which churns out $3. United States. An AP review of 1. Food and Drug Administration reports shows even modern drug plants here under the watch of U. S. Sidney Wolfe of the Washington watchdog group Public Citizen. Consumer advocates say they demonstrate the regulatory agency does not sufficiently monitor the industry across Puerto Rico and in the mainland. The FDA issued a warning letter to Wyeth in May 2. Effexor, a leading depression treatment, and the heartburn drug Protonix. The letter expressed concern that the plant was not . In another case cited in a June 2. FDA inspection report, a plant owned by Teva Pharmaceutical Industries exported drugs - including the diabetes treatment metformin - even though they were known to contain small amounts of metal particles. The company had also received at least six consumer complaints of dark residue inside bottles or foreign material embedded in tablets, according to the report. Teva's quality- control unit said the presence of some metallic material was to be expected because the manufacturing equipment is made of metal, according to the report. Teva recalled 2. 1 different drugs as a result of the inspection, according to FDA officials, and the Israeli drugmaker announced two months later it was closing the plant, citing a restructuring. Denise Bradley, a Teva spokeswoman, insisted the medicine from the now- closed plant was safe and effective despite the contamination. The reports obtained by AP were produced by FDA inspections from 2. U. S. Several are closing or downsizing as the expense of updating decades- old plants to meet regulations adds to struggles with rising energy costs and tightening tax breaks. The FDA often hesitates to crack down at the first sign of problems because manufacturers can chalk them up to isolated mishaps, said John Scharmann, a former FDA administrator for the Denver district now associated with a watchdog group. That appeared to be the case at the Biovail- owned factory in the San Juan suburb of Carolina where the sharp- eyed worker noticed the foreign specks of blue. David Elder, director of enforcement in FDA's regulatory affairs office, said pharmaceutical companies generally fix problems on their own and issue recalls if necessary once notified. One of those four, Glaxo.
Life at Samsung Electronics; Our People; Benefits; Career Development; Community; Tech Institute; Samsung Group Blog; Business Ethics; Opportunities. Inspire the World, Create the Future. Product Open sub menu. Valeant Pharmaceuticals International, Inc. Biovail Acquired Valeant in 2010 and renamed itself Valeant. Toronto, Canada Clinical Trials. Toronto Memory Program. Biovail Contract Research.Smith. Kline PLC, produced tablets of the popular antidepressant Paxil CR that split apart, potentially causing patients to take incorrect dosages. When the company would not recall all the affected pills, U. S. Some plants in Puerto Rico are three decades old, built when the territory's pharmaceutical industry took off thanks to tax incentives aimed at developing more high- tech manufacturing. CPPIB buys 50% stake in OMERS' Toronto, Calgary offices for $1.2 billion. Vancouver foreign buyers tax was the right move. Oil patch sentiment worse than National Energy Program: Ex-Encana CEO. HBC happy with stores it has. The industry here has faded somewhat. Companies have shed more than 3,0. Still, this island turns out some top- selling drugs on the U. S. The FDA's San Juan office has 2. They typically visit the factories once every two years, more often if there are consumer complaints or the company has repeated infractions. Factories confronted with violations often make extensive changes. The Biovail plant invested $5 million in equipment upgrades and addressed problems including errant metal particles from cleaning spatulas. A follow- up FDA inspection found no problems, said Gilbert Godin, executive vice- president of the Ontario- based company. Scharmann, a consulting editor for the watchdog publication Dickinson's FDA Review, said the FDA is concerned by anything that affects drug quality but considers the likelihood that the companies may file legal challenges to enforcement actions. Elder contends inspections are rigorous. That's our job, but we're also consumers of these products.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. Archives
January 2017
Categories |